ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER


Device Classification Name

screw, fixation, bone

510(k) Number K021832
Device Name ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER
Original Applicant
BIOMET, INC.
56 east bell dr.
po box 587
warsaw, 
IN 
46581 -0587

Original Contact sara b shultz
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 06/04/2002
Decision Date 06/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No